Light Adjustable Lens (LAL) 60007-0225Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00818806021637), received between Jul 12, 2024 and Jun 16, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Device Dislodged or Dislocated

  A SITE REPORTED THAT A PATIENT EXPERIENCED AN ANTERIOR DISLOCATION OF A SULCUS-FIXATED LIGHT ADJUSTABLE LENS+ (LAL+) FOLLOWING A YAG CAPSULOTOMY. THE LENS IS REPORTED TO BE IN CONTACT WITH THE IRIS, WITH ASSOCIATED PIGMENT DISPERSION AND ELEVATED INTRAOCULAR PRESSURE (IOP). THE PATIENT WAS TREATED WITH A BETA-BLOCKER AND A CARBONIC ANHYDRASE INHIBITOR FOR MANAGEMENT OF THE INCREASED IOP. THE PATIENT IS REPORTED TO BE RESPONDING WELL TO TREATMENT AND SATISFIED WITH THEIR VISUAL OUTCOME. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 25521370 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+) WAS EXPLANTED FROM THE LEFT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND BLURRED DISTANCE VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25306678 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +22.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCE AND A NEW LIGHT ADJUSTABLE LENS (LAL) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24263646 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +22.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCE AND A NEW LIGHT ADJUSTABLE LENS (LAL) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24263643 ↗
• InjuryDec 31, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS BILATERALLY IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) IN THE LEFT EYE ON (B)(6) 2024. POSTOPERATIVELY, THE PATIENT COMPLETED 1 LIGHT ADJUSTMENT IN THE LEFT EYE BUT DELAYED THE LOCK IN TREATMENT DUE TO DRY EYE TREATMENT AND LIGHT ADJUSTMENT OF THE RIGHT EYE. UPON EXAMINATION ON (B)(6) 2025, THE TREATING PHYSICIAN OBSERVED CENTRAL INTRAOCULAR LENS IRREGULARITIES CONSISTENT WITH POLYMERIZATION. LOCK IN TREATMENT WAS PERFORMED ON THE SAME DAY. A PROCEDURE WAS ATTEMPTED ON (B)(6) 2025 TO EXPLANT THE LENS, HOWEVER, DUE TO ZONULAR DEHISCENCE THE PROCEDURE WAS NOT COMPLETED. ON (B)(6) 2025, APPROXIMATELY 12 MONTHS AFTER IMPLANTATION, THE LAL+ WAS EXPLANTED AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23936879 ↗
• InjuryDec 31, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS BILATERALLY IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) IN THE RIGHT EYE ON (B)(6) 2024. POSTOPERATIVELY, THE PATIENT COMPLETED 3 LIGHT ADJUSTMENTS IN THE RIGHT EYE. UPON EXAMINATION ON (B)(6) 2025, THE TREATING PHYSICIAN OBSERVED CENTRAL INTRAOCULAR LENS IRREGULARITIES CONSISTENT WITH POLYMERIZATION. LOCK-IN TREATMENT WAS PERFORMED ON THE SAME DAY. A PROCEDURE WAS ATTEMPTED ON (B)(6) 2025 TO EXPLANT THE LENS, HOWEVER, DUE TO ZONULAR DEHISCENCE, THE PROCEDURE WAS NOT COMPLETED. ON (B)(6) 2025, APPROXIMATELY 12 MONTHS AFTER IMPLANTATION, THE LAL+ WAS EXPLANTED AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23936878 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +22.5D) WAS ATTEMPTED TO BE EXPLANTED ON (B)(6) 2025 DUE TO PATIENT DISSATISFACTION WITH THEIR VISION, HOWEVER, THE SURGEON STRUGGLED TO REMOVE THE LENS DUE TO A SMALL CAPSULORHEXIS AND THE LENS WAS LEFT IN THE CAPSULAR BAG.

  Patient problems: Blurred Vision

  MAUDE report 23556404 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRED VISION AND VISUAL DISTURBANCES. A NEW LIGHT ADJUSTABLE LENS WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23490406 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23417399 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +23.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23415777 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET. A NEW LAL+ (SN, (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23358884 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AFTER FINAL LOCK IN.

  Patient problems: Blurred Vision

  MAUDE report 23358883 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 22953572 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +22.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH CHOSEN REFRACTIVE TARGET. A NEW LAL+ (B)(6), +22.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22330222 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6)) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22303281 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.50D) WAS IMPLANTED ON (B)(6) 2024. AFTER 2 LIGHT TREATMENTS IN THE RIGHT EYE, A PHOTOREFRACTIVE KERATECTOMY (PRK) ENHANCEMENT WAS PERFORMED ON THE RIGHT EYE TO ATTEMPT TO NORMALIZE THE CORNEAL SURFACE. POST PRK ENHANCEMENT, THE PATIENT CONTINUED TO REPORT BLURRY DISTANCE VISION AND GLARE AT NIGHT SO THE DECISION WAS MADE TO EXPLANT THE LAL+ ON (B)(6) 2025.

  Patient problems: Blurred Vision

  MAUDE report 22080208 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH SIGNIFICANT HISTORY OF OCULAR SURFACE AND CORNEAL DISEASE WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) ON (B)(6) 2023. APPROXIMATELY 15 MONTHS LATER ON 2/7/2025, THE LAL+ WAS EXPLANTED DUE TO THE PATIENT DISSATISFACTION WITH VISION. ANOTHER LAL+ (SN (B)(6), +22.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 21575599 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING THE IMPLANTATION OF A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D). THE LAL+ WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND ANOTHER LAL+ WAS IMPLANTED INTO THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 21356900 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT THE PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH THEIR DISTANCE VISION AS A RESULT OF THE REFRACTIVE TARGET CHOSEN AND A NEW LAL (SN (B)(6), +21.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21181026 ↗
• InjuryDec 9, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS IMPLANTED DURING PRIMARY CATARACT SURGERY ON (B)(6) 2024. DURING THE POSTOPERATIVE PERIOD, THE LAL+ WAS OBSERVED TO BE DECENTERED. ON (B)(6) 2024, A SECONDARY PROCEDURE TO REPOSITION THE LAL+ WAS PERFORMED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20887227 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), 22.5D) HAD BEEN EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES. THE LENS WAS REPLACED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 23.0D).

  Patient problems: Visual Disturbances

  MAUDE report 20764533 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +22.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR DISTANCE VISION EVEN THOUGH IT WAS MEASURED AT 20/20. THE LAL+ WAS REPLACED WITH A NEW LIGHT ADJUSTABLE LENS (SN: (B)(6), +22.5D).

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20725668 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RXSIGHT WAS INFORMED OF A REPORT THAT A POSTERIOR CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +22.5D). A VITRECTOMY WAS PERFORMED, AND THE LAL+ WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 20667408 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 20665868 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN 8(B)(6), +22.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO DISSATISFACTION WITH VISION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024. REFERENCE REPORT #3012712027-2024-00100 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 19735250 ↗